Focus on Quality

Facet Medical’s Quality Management System is dedicated to consistently providing products that exceed customer expectations and comply with regulatory requirements.

Quality Policy

The entire organization is committed to providing medical devices and services that meet patient, regulatory, and customer requirements through an effective Quality Management System that pursues continual improvement.

• Our Quality Management Team is involved in every step throughout the product lifecycle.
• Quality Control for incoming components, in process inspection, and finished goods.
• Quality Assurance for testing and validation of design and processes.
• Establishment of sampling plans for inspection and testing.
• Internal audits to ensure the Quality Management System is effective.
• Facet Medical rigorously follows the requirements outlined in 21 CFR 820, the US Food and Drug Administration’s Quality System Regulation (QSR).

Credentials – Download Files

• ISO 13485 Certification
• Medical Device Directive 93/42/EEC including Annex II

Registration Information

FDA Registration

• Registration Number: 3011617315

Health Canada Registration

• Registration Number: 130091